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Development of a Dietary Intervention Model Based on Genetic Data as an Implementation of a Healthy Lifestyle in the Management of Systemic Lupus Erythematosus Patients

NCT07183007 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-09-19

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if dietary intervention based on genetic data benefits in the management of systemic lupus erythematosus patients. It will also learn about the safety of this intervention. The main questions it aims to answer are:

* What is the effect of dietary intervention based on genetic data as part of a healthy lifestyle in the management of SLE patients on disease activity?
* What is the effect of dietary intervention based on genetic data as part of a healthy lifestyle in the management of SLE patients on quality of life Researchers would compare dietary intervention based on genetic data to a no intervention to see if dietary intervention based on genetic data improves disease activity and quality of life of SLE patients.

Participants will:

* Be checked for genetic test (HLA DQ2 and DQ8) as screening
* Be randomized to dietary intervention group or control group if has HLA DQ2 or DQ8 positive from screening
* Visit the clinic once every month for checkups and lab test if were randomized to dietary intervention group or control group
* Do food record as instructed if were randomized to dietary intervention group or control group

Conditions

Interventions

OTHER

Low gluten diet

Systemic lupus erythematosus patients with HLA-DQ2 or DQ-8 positive will be randomized to dietary intervention group or control group. Those who are randomized to dietary intervention group will get dietary planning and intervention from a nutritionist with low gluten diet

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-21
Primary Completion
2025-12-31
Completion
2026-03-31

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07183007 on ClinicalTrials.gov